Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

ADARx Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: IgA Nephropathy (IgAN); IC-MPGN; C3G; Complement-mediated Kidney Disease; IgAN

Treatments: Drug: ADX-038 Dose Level 1; Drug: ADX-038 Dose Level 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06989359

ADX-038-201

Details and patient eligibility

About

This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mean eGFR
• Clinical evidence of active kidney disease
• Been on supportive care
• vaccine requirements
• Females must not be pregnant or breastfeeding
• Men must agree to use acceptable contraception and not donate sperm
• IgAN: confirmed disease by kidney biopsy performed within 60 months prior to screening
• C3G/IC-MPGN: confirmed disease by kidney biopsy performed within 18 months prior to screening

Exclusion criteria

• Hereditary or acquired complement deficiency
• Kidney transplant or renal replacement therapy
• History of solid organ transplant
• Other kidney disease
• History of recurrent invasive infections
• Received complement inhibitor treatments
• Active systemic viral, bacterial, or fungal infection
• Liver dysfunction
• No donating blood

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

ADX-038 Dose Level 1 - IgAN

Experimental group

Treatment:

Drug: ADX-038 Dose Level 1

ADX-038 Dose Level 1 - C3G

Experimental group

Treatment:

Drug: ADX-038 Dose Level 1

ADX-038 Dose Level 2 - IgAN

Experimental group

Treatment:

Drug: ADX-038 Dose Level 2